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Phase 4 N=35 Basic Science

UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study

Unconsciousness · Consciousness

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Occipital Delta Power Spectral Density by Conscious State and Study Group. — 2.37; 1.62; 2.05; 2.1 log10(μV^2) — p=0.012

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Dexmedetomidine (Drug); Ketamine (Drug); Propofol (Drug); Midazolam (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Wisconsin, Madison
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Occipital Delta Power Spectral Density by Conscious State and Study Group.
2.37; 1.62; 2.05; 2.1; 2.57; 1.7 0.012 sig
SECONDARY
Number of Instances of Disconnected Conscious Experience (Dreaming) vs Connected Conscious Experience (Awareness of External World).
70; 180; 56; 226; 30; 22
SECONDARY
Effect of Study Drug on Ability to Correctly Identify Shapes/Images
8.83; 9.29; 9.45; 7.85; 8.2; 6.94 0.134
SECONDARY
Effect of Study Drug on Ability to Correctly Identify Images
0.916; 0.899; 0.91; 0.793; 0.763; 0.734 <0.001 sig
SECONDARY
Effect of Study Drug on Ability to Form Implicit Memory
8; 8.17; 9 0.5

Summary

This study will be a single-site, controlled, unblinded study at the University of Wisconsin to examine changes in the electroencephalogram during anesthesia and waking.

Eligibility Criteria

Inclusion Criteria

  • Age 18-40
  • In good health, determined by the PI on the basis of medical history and a standard assessment for anesthesia to be documented as part of the study record
  • Right handed, to standardize for asymmetry in brain functions

Exclusion Criteria

  • Adults 40 years old
  • Pregnancy confirmed on pregnancy test on day of sedation
  • Contraindication to anesthesia or allergy to study drug
  • Difficult anesthesia: American Society of Anesthesiologists Physical Status greater than 1, per the discretion of the PI. Examples of ASA status include, but are not limited to:
  • Any systemic disease present, such as diabetes, cardiac, pulmonary, or other acute or chronic disorder, or history of smoking
  • Narrow angle glaucoma
  • Abnormal airway examination
  • Any abnormality on medical history and physical examination
  • Snoring or sleep disorders including apnea
  • Antecedent pulmonary aspiration risk (e.g., history GI reflux, heartburn, hiatal hernia)
  • Adverse reaction or allergy with anesthesia or other sedatives
  • Chronic medication use
  • History of difficult anesthesia, laryngoscopy or intubation
  • Family history of difficulty with anesthesia or sedation
  • History of vertigo, nausea or vomiting after anesthesia
  • BMI > 35
  • Contraindication to HD-EEG, TMS or MRI for relative parts of the procedures. MRI exclusion criteria: presence of metallic or electronic implants; history of claustrophobia. TMS exclusion criteria: Presence or history of medical conditions that could increase the chance of seizures (e.g. - stroke, aneurysm, brain surgery, structural brain lesion) cranial metal implants; structural brain lesion; devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator); history of head trauma with loss of consciousness for greater than 5 minutes; family history of seizures; history of antecedent mood disorder.
  • Exclusion from Dexmedetomidine:

o Resting heart Rate<60 bpm

  • Exclusion from Propofol:

o Reported egg allergy

  • Exclusion from Ketamine:
  • History of post-operative nausea and vomiting
  • History of motion sickness

Additional exclusion criteria on the day of sedation:

  • Anything to eat or drink for the preceding 8 hours
  • Any use of over-the-counter or recreational drugs (including alcohol or tobacco) within the preceding 24 hours
  • Any use of sedative or sleep agents within the preceding 24 hours
  • Recent change in health, including cough, cold, or fever
  • Exposure to anesthesia or sedation in the last 6 days
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03284307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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